Parameter Refinement for ECT Stimulation and Titration Optimization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Brain hemodynamics
研究概览
简要总结
The goal of this clinical trial is to improve how electroconvulsive therapy (ECT) stimulation settings are chosen. Researchers will use real-time brain monitoring to measure both seizures and a recently identified brain event called cortical spreading depolarization (CSD).
The main questions it aims to answer are:
What is the best way to increase ECT stimulation settings? How do different pulse settings affect the brain's response? Can certain settings produce CSD without causing a seizure?
Participants already receiving ECT as part of their care will take part. They will be assigned to one of two groups:
Index ECT group: Participants starting ECT will receive different standard titration approaches.
Maintenance ECT group: Participants receiving ongoing ECT will undergo a brief, low-dose stimulation test before treatment.
All participants will be monitored using brain physiology (EEG and blood flow) and symptom scales during treatment.
详细描述
This is an exploratory, single-center open-label clinical trial at Pennsylvania Hospital (PAH) intended to optimize stimulation settings for electroconvulsive therapy (ECT), guided by real-time monitoring of both seizure and a recently discovered postictal event: cortical spreading depolarization (CSD). We will address three key questions: 1. What is the best strategy for up-titrating settings for ECT?; 2. How do individual pulse parameters impact brain evoked response?; 3. Are there stimulation settings that directly induce CSD waves without seizure?
This study will take place in the context of routine treatments for patients already consenting to receive ECT for a wide range of clinical indications. Patients will be enrolled in one of two arms:
- Index Titration Arm: Patients coming in for initial index ECT courses (acute phase) will be randomized to one of several stimulation parameter titration tables while receiving otherwise routine ECT care.
- Maintenance Arm: In clinically stable patients receiving monthly maintenance ECT, a sub-convulsive stimulation settings ramp will be performed under anesthesia immediately preceding their regular ECT treatment.
All patients being treated with ECT at PAH are eligible for this study. Outcomes will include non-invasive monitoring of brain hemodynamics and EEG as well as clinical symptom scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patients being treated with electroconvulsive therapy at Pennsylvania Hospital who are willing and able to participate are eligible to be subjects in this study.
排除标准
- •They are unwilling or unable to consent first to the SWEET COMBO protocol for optical monitoring during ECT
- •Clinically significant psychiatric comorbidity as determined by clinical interview and in the opinion of the Investigator and clinical team would alter the risk/benefit of the study
- •History of poor response to ECT treatment in the opinion of the Investigator and clinical team that would alter the risk/benefit of the study
- •Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise, interfere with, limit, affect or reduce the:
- •subject's ability to participate safely in the study
- •integrity of the data or
- •subject's ability to complete the full duration of the study.
研究组 & 干预措施
Index: Standard titration table
Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)
干预措施: Electroconvulsive Therapy (Procedure)
Index: Frequency-then-duration
ECT provided using Table 2, frequency uptitration followed by duration uptitration
干预措施: Electroconvulsive Therapy (Procedure)
Index: Duration then Frequency
ECT provided using Table 3, duration titration then frequency titration
干预措施: Electroconvulsive Therapy (Procedure)
Maintenance
Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols
干预措施: Electroconvulsive Therapy (Procedure)
结局指标
主要结局
Brain hemodynamics
时间窗: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Functional near infrared spectroscopy imaging will be performed during each ECT treatment, from which we will extract oxy- and deoxyhemoglobin concentrations (in mM) over time.
Electroencephalography - Seizure Duration
时间窗: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Bilateral EEG over FP1 and FP2 zones, from which we will compute seizure duration (in seconds)
Electroencephalography - theta band power
时间窗: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)
Electroencephalography - Brain Symmetry Index
时间窗: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)
次要结局
- Quick Inventory of Depression Self-Report(Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.)
- Bush Francis Catatonia Rating Scale(Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.)
- Single Letter Fluency(Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.)
- 3 word registration and recall(Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.)
- Psychotic Depression Assessment Scale (PDAS)(Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients)
- Clinical Global Impressions Scale for Severity and Improvement(Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.)
研究者
Zach Rosenthal
Attending Physician
University of Pennsylvania